Trade Name: Tigecycline

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/5mL

Storage and handling

TIGECYCLINE Tetracycline-class Antibacterial [EPC],Tetracyclines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Tigecycline (Tigecycline) which is also known as Tigecycline and Manufactured by Amneal Biosciences LLC. It is available in strength of 50 mg/5mL.

Tigecycline (Tigecycline) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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  • Dosage and Administration, Monitoring of Bloodu00a0Coagulation Parameters u00a0u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 07/2020
  • Warning and Precautions, Monitoring of Bloodu00a0Coagulation Parameters u00a0u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a007/2020
  • WARNING: ALL-CAUSE MORTALITY n n
  • Tigecycline is a tetracycline class antibacterial indicated in patients 18 years of age and older for:
  • Limitations of Use:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline and other antibacterial drugs, Tigecycline should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.u00a0n
  • Complicated skin and skin structure infections u00a0
  • Complicated intra-abdominal infections u00a0
  • Community-acquired bacterial pneumonia u00a0
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  • Initial dose of 100 mg, followed by 50 mg every 12 hours administered by intravenous infusion over approximately 30 minutes to 60 minutes. u00a0
  • Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. u00a0
  • See Full Prescribing Information for instructions on reconstitution of the lyophilized powder, and preparation and administration of the intravenous infusion. n
  • For Injection: Each single-dose glass vial contains 50 mg of tigecycline, USP as an orange lyophilized powder for reconstitution.
  • For Injection: 50 mg, lyophilized powder for reconstitution in a single-dose vial. n
  • Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. Reactions have included anaphylactic reactions andu00a0n
  • Known hypersensitivity to tigecycline. u00a0
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  • All-Cause Mortality
  • Anaphylactic Reactions
  • Hepatic Adverse Effects
  • Pancreatitis
  • Monitoring of Blood Coagulation Parameters:u00a0
  • Tooth Discoloration and Enamel Hypoplasia
  • Inhibition of Bone Growth
  • Arrayn- associated Diarrhea (CDAD)
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased serum glutamic pyruvic transaminase (SGPT). n n
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  • Warfarin: Suitable anticoagulation test should be monitored if tigecycline is administered to patients receiving warfarin. u00a0
  • Calcineurin Inhibitors
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  • Lactation:
  • Pediatrics:
  • No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.
  • Tigecycline, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline, USP is (4,4a,5a,12a)-9-[2-(-butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The empirical formula is CHNO and the molecular weight is 585.65.
  • The following represents the chemical structure of tigecycline, USP:
  • Figure 1: Structure of Tigecycline
  • Tigecycline, USP is an orange lyophilized sterile powder or cake. Each Tigecycline for injection, USP single-dose 5 mL vial contains 50 mg tigecycline, USP lyophilized powder for reconstitution for intravenous infusion and 50 mg of L-Arginine. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives.
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  • Tigecycline for injection, USP is available in a single-doseu00a05 mL glass vialu00a0containing 50 mg tigecycline, USP as an orange lyophilized powder for reconstitution.
  • It is supplied as:u00a0
  • 5 mL glass vial containing 50 mg tigecycline, USPu00a0- 10 vials/box. NDC 70121-1647-7
  • Prior to reconstitution, Tigecycline for injection, USP should be stored at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].u00a0
  • The reconstituted solution of tigecycline for injection, USPu00a0may be stored at room temperature (not to exceed 25u00b0C/77u00b0F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag).
  • Tooth Discoloration and Inhibition of Bone Growth
  • Advise pregnant women that Tigecycline for injection may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy andu00a0n
  • Lactation
  • Advise a woman not to breastfeed for longer than 3 weeks while taking Tigecycline for injection because of the lack of data on effects due to prolonged breastfeeding, and the theoretical risk of dental discoloration and inhibition of bone growth. Women may also consider reducing infant exposure through pumping and discarding breastmilk during and for 9 days after the last dose of tigecycline .
  • Diarrhea
  • Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including Tigecycline for injection. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact his or her healthcare provider n
  • Development of Resistance
  • Patients should be counseled that antibacterial drugs including Tigecycline for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tigecycline is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by tigecycline or other antibacterial drugs in the future.
  • This productu2019s label may have been updated. For current full prescribing information, please visit: www.amneal.com
  • Distributed byn Bridgewater, NJ 08807
  • Made in India
  • Rev 07-2020-02
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